New 
Quality Assurance Senior Associate
 Spectraforce Technologies | |
 United States, North Carolina, Holly Springs | |
 Aug 02, 2026 | |
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Job Title: Sr. Associate Plant Quality Assurance (PQA) - On-the-Floor
Location: Fully Onsite - Client North Carolina (ANC) Schedule: Shift Work (includes weekends, and possibly nights). Shift will be determined once identified; once determined, shifts will be on a stable schedule. Must Have: Manufacturing and PQA background Duration: 12 Months (Possibility of Extension) Position Overview: Our North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. Day to Day Responsibilities: * Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Client Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support. * Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. * Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. * Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations. * Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. * Oversee and provide guidance during on-the-floor analytical testing. * Ensure that changes that could potentially impact product quality are assessed according to procedures. * Ensure that deviations from established procedures are investigated and documented per procedures. * Alert senior management of quality, compliance, supply and safety risks. * Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. * Identification and implementation of continuous improvement opportunities within our processes and systems. * Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Basic Qualifications: High school/GED + 4 years work experience OR Associate + 2 years work experience OR Bachelor + 6 months work experience OR Masters Degree Top Must-Have Skill Sets: * Strong cGMP and GDP behaviors * Experience in biotechnology; knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment * Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation * Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems Possible Extension: Yes Red Flags: * No prior experience in Mfg / PQA * No GMP and GMP behavior knowledge * No previous work with quality systems Interview Process: 2 panel interview | |